Aligning Medications With What Matters Most

NCT04938648 | Completed Results

• 2 other identifiers: IRB002863535U54AG063546-02
• Study Type: interventional
• Target: 138
• Locations: 1 country
• Sites: 2

Brief Summary

The Aligning Medications with What Matters Most (ALIGN) study will assess the feasibility and preliminary efficacy of a deprescribing intervention to reduce medication regimen complexity and treatment burden for people living with dementia (PLWD) and their care partners.

Conditions

Polypharmacy; Alzheimer Disease and Related Dementias

Keywords

Deprescribing

Outcome Measures

Primary Outcomes (8)

• Feasibility as Assessed by Proportion of Dyads That Opt Out of the Intervention

  Dyads are comprised of the person living with dementia and their care partner. We will measure the proportion of dyads that opt out of the intervention versus the dyads that agree to participate.

  A duration of approximately 8 months

• Feasibility as Assessed by the Number of Pharmacist Messages to the Primary Care Provider (PCP) That Receive an Acknowledgment or Response

  We will measure the number of pharmacist's messages that receive an acknowledgment or response from the PCP based on Electronic Medical Record (EMR) review

  3 months after enrollment

• Feasibility as Assessed by the Number of Contacts Between Pharmacist and PCP

  We will measure the number of contacts between pharmacist and PCP based on Electronic Medical Record (EMR) review

  3 months after enrollment

• Feasibility as Assessed by the Number of Contacts Between Pharmacist and Dyad

  We will measure the number of contacts between pharmacist and PCP and dyad based on Electronic Medical Record (EMR) review

  3 months after enrollment

• Feasibility as Assessed by the Direct Time Required by the Pharmacist to Complete the Intervention

  We will measure the amount of direct time that it takes the pharmacist to complete the intervention. We will access from pharmacist's documentation in the Electronic Medical Record (EMR).

  3 months after enrollment

• Feasibility as Assessed by the Indirect Time Required by the Pharmacist to Complete the Intervention

  We will measure the amount of indirect time that it takes the pharmacist to complete the intervention. We will access from pharmacist's documentation in the Electronic Medical Record (EMR).

  3 months after enrollment

• Feasibility as Assessed by Percentage of Dyads Who Complete 2 of 2 Pharmacist Phone Calls Based on Documented Status Reports

  Dyads are comprised of the person living with dementia and their care partner. We will measure the percentage of dyads who complete 2 of 2 pharmacist phone calls based on documented status reports

  Baseline and 3 months after enrollment

• Acceptability Will be Assessed by the Acceptance Rates for the Pharmacist's Recommendations

  We will measure the acceptance rates for the pharmacist's recommendations as documented in the Electronic Medical Record (EMR)

  3 months after enrollment

Secondary Outcomes (6)

• Total Medication Count

  Baseline and 3 months after enrollment

• Percentage of Participants With Data Elements Available to Calculate the Medication Regimen Complexity Index (pMRCI)

  Baseline and 3 months after enrollment

• Medication Regimen Complexity Index (MRCI)

  Baseline and 3 months Baseline and 3 months after enrollment

• Response Rate for the Family Caregiver Medication Administration Hassles Scale (FCMAHS)

  Baseline and 3 months after enrollment

• Time to Complete the Family Caregiver Medication Administration Hassles Scale (FCMAHS)

  Baseline and 3 months after enrollment

Study Arms (2)

Intervention

EXPERIMENTAL

The intervention consists of the following: 1. mailing deprescribing educational materials to care partners and people living with dementia (PLWD); 2. dyads will receive a telehealth visit with a clinical pharmacist to discuss the benefits and harms of the patient's medications with the patient and care partner in the context of their goals and preferences; 3. pharmacist- primary care provider (PCP) communication in which the pharmacist provides tailored deprescribing recommendations to the PCP.

Behavioral: Pharmacist-led deprescribing intervention

Delayed Intervention (wait list control)

ACTIVE COMPARATOR

The delayed intervention consists of the following: 1. mailing deprescribing educational materials to care partners and people living with dementia (PLWD); 2. three months after mailing the deprescribing educational materials, dyads will receive a telehealth visit with a clinical pharmacist to discuss the benefits and harms of the patient's medications with the patient and care partner in the context of their goals and preferences. 3. pharmacist- primary care provider (PCP) communication in which the pharmacist provides tailored deprescribing recommendations to the PCP.

Behavioral: Pharmacist-led deprescribing intervention

Interventions

Pharmacist-led deprescribing intervention BEHAVIORAL

1\) direct-to-consumer deprescribing educational materials designed to activate the care partner and people living with dementia PLWD; 2) a telehealth visit in which a clinical pharmacist discusses benefits and harms of the patient's medications with the patient and care partner in the context of their goals and preferences; and 3) pharmacist-PCP communication in which the pharmacist provides tailored deprescribing recommendations designed to be useful and actionable for the PCP

Delayed Intervention (wait list control); Intervention

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• Age 65 or greater
• Diagnosis of dementia from International Classification of Diseases (ICD) -9 or ICD-10 codes
• At least one other chronic condition
• Five or more chronic medications (to include all prescription and over-the-counter medications, both scheduled and as needed)
• Have a primary care physician at the pilot clinic who has enrolled in the study; this will be defined as having had at least 1 previous visit with that physician
• Care partners:
• \- Family or other companions age 21 years or greater who regularly help the patient with managing medications

You may not qualify if:

• As both the pilot and the planned pragmatic trial will be based in primary care, individuals residing in long term care facilities or enrolled in hospice will be excluded.
• Individuals who cannot converse comfortably in English will be excluded because the FCMAHS has not been validated in other languages.

Sponsors & Collaborators

• Johns Hopkins University: lead
• Kaiser Permanente: collaborator
• National Institute on Aging (NIA): collaborator

Study Sites (2)

Kaiser Permanente

Aurora, Colorado, 80014, United States

Location

Johns Hopkins Bayview Medical Center

Baltimore, Maryland, 21224, United States

Location

Related Publications (9)

• Boyd CM, Darer J, Boult C, Fried LP, Boult L, Wu AW. Clinical practice guidelines and quality of care for older patients with multiple comorbid diseases: implications for pay for performance. JAMA. 2005 Aug 10;294(6):716-24. doi: 10.1001/jama.294.6.716.

  PMID: 16091574 BACKGROUND

• Alzheimer's Association. 2016 Alzheimer's disease facts and figures. Alzheimers Dement. 2016 Apr;12(4):459-509. doi: 10.1016/j.jalz.2016.03.001.

  PMID: 27570871 BACKGROUND

• Lin PJ, Fillit HM, Cohen JT, Neumann PJ. Potentially avoidable hospitalizations among Medicare beneficiaries with Alzheimer's disease and related disorders. Alzheimers Dement. 2013 Jan;9(1):30-8. doi: 10.1016/j.jalz.2012.11.002.

  PMID: 23305822 BACKGROUND

• Kelley AS, McGarry K, Gorges R, Skinner JS. The burden of health care costs for patients with dementia in the last 5 years of life. Ann Intern Med. 2015 Nov 17;163(10):729-36. doi: 10.7326/M15-0381. Epub 2015 Oct 27.

  PMID: 26502320 BACKGROUND

• Willson MN, Greer CL, Weeks DL. Medication regimen complexity and hospital readmission for an adverse drug event. Ann Pharmacother. 2014 Jan;48(1):26-32. doi: 10.1177/1060028013510898. Epub 2013 Nov 5.

  PMID: 24259639 BACKGROUND

• Bayliss EA, Shetterly SM, Drace ML, Norton J, Green AR, Reeve E, Weffald LA, Wright L, Maciejewski ML, Sheehan OC, Wolff JL, Gleason KS, Kraus C, Maiyani M, Du Vall M, Boyd CM. The OPTIMIZE patient- and family-centered, primary care-based deprescribing intervention for older adults with dementia or mild cognitive impairment and multiple chronic conditions: study protocol for a pragmatic cluster randomized controlled trial. Trials. 2020 Jun 18;21(1):542. doi: 10.1186/s13063-020-04482-0.

  PMID: 32552857 BACKGROUND

• Group Health Research Institute. The Chronic Care Model. Available at http://www.improvingchroniccare.org/index.php?p=CCM_Gallery&s=149. Accessed August 21, 2020

  BACKGROUND

• George J, Phun YT, Bailey MJ, Kong DC, Stewart K. Development and validation of the medication regimen complexity index. Ann Pharmacother. 2004 Sep;38(9):1369-76. doi: 10.1345/aph.1D479. Epub 2004 Jul 20.

  PMID: 15266038 BACKGROUND

• Travis SS, Bernard MA, McAuley WJ, Thornton M, Kole T. Development of the family caregiver medication administration hassles scale. Gerontologist. 2003 Jun;43(3):360-8. doi: 10.1093/geront/43.3.360.

  PMID: 12810899 BACKGROUND

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Results Point of Contact

• Title: Dr. Ariel Green
• Organization: Johns Hopkins University

ariel@jhmi.edu

(410) 550-6733

Study Officials

• Ariel Green, MD, MPH, PhD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patient and care partner dyads are randomly assigned to receive the pharmacist-led intervention immediately after an educational mailing or to a delayed intervention control group that will receive the pharmacist-led component 3 months after the mailing.

Study Record Dates

• First Submitted: June 15, 2021
• First Posted: June 24, 2021
• Study Start: June 3, 2021
• Primary Completion: May 2, 2022
• Study Completion: May 2, 2022
• Last Updated: May 26, 2023
• Results First Posted: May 26, 2023

Record last verified: 2023-05

Locations

US (2)